UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050232 |
|---|---|
| Receipt number | R000057210 |
| Scientific Title | Investigation of the effect of nordic walking exercise training in young adults with Covid 19 infection. |
| Date of disclosure of the study information | 2023/03/04 |
| Last modified on | 2023/02/03 21:37:58 |
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Basic information
Public title
Nordic walking - the effectiveness of a new form of exercise in adults after COVID-19 infection: A randomized controlled trial
Acronym
the effectiveness of a new form of exercise in adults after COVID-19 infection
Scientific Title
Investigation of the effect of nordic walking exercise training in young adults with Covid 19 infection.
Scientific Title:Acronym
the effect of nordic walking exercise training in young adults with Covid 19 infection.
Region
| Asia(except Japan) |
Condition
Condition
It's almost finished
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of study is investigating the effects of Nordic walking exercise (NWE) on physical activity, physical fitness, anxiety-depression, dyspnea, fatigue, functional status and quality of life in adults after COVID-19 infection undergoing home isolation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
physical activity, physical fitness, quality of life
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
nordic walking exercise/
Interventions/Control_2
no exercise
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The individuals with COVID-19 symptoms such as fever, pain, cough, loss of sense of taste and smell while PCR tests are positive who had been diagnosed at least 3 months and at most of 10 months past after the diagnosis of COVID-19 infection and treated with home isolation, were aged between 18 and 50 years were enrolled in this study.
Key exclusion criteria
The exclusion criterias of study were being musculoskeletal, neuromuscularand cardiovascular system diseases that may prevent exercise tests and training, being hospitalized for COVID-19 treatment (with severe effects), having no symptoms while PCR positive, undergone surgery in the last six months and cooperation problems who will reduce compliance with the exercise program and assessment methods.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Manolya |
| Middle name | |
| Last name | acar |
Organization
Baskent University
Division name
physiotherapy and rehabilitation
Zip code
06790
Address
basket university, heakth science faculty, physiotherapy and rehabilitation
TEL
03122466666
manolya@baskent.edu.tr
Public contact
Name of contact person
| 1st name | Manolya |
| Middle name | |
| Last name | acar |
Organization
Baskent Univesity
Division name
physiotherapy and rehabilitation
Zip code
06790
Address
basket university, heakth science faculty, physiotherapy and rehabilitation
TEL
03122466666
Homepage URL
manolya@baskent.edu.tr
Sponsor or person
Institute
Baskent university
Institute
Department
Personal name
Funding Source
Organization
Baskent university
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Baskent University
Address
basket university, health science faculty, physiotherapy and rehabilitation
Tel
03122466666
manolya@baskent.edu.tr
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 03 | Day |
Last modified on
| 2023 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057210
